Vertex Pharmaceuticals

Compliance

• Provides specialized knowledge on region/country regulations and requirements governing product promotion and related communications
• Serves as regulatory reviewer for assigned product(s) on Communications Review Committee (CRC) and Medical Review Committee (MRC)
• In collaboration with Medical, Legal and Commercial, provides regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications
• Monitors and interprets advertising and promotion regulations and guidelines to support successful and compliant marketing of Vertex products
• Plans and conducts training sessions as needed with stakeholders

Associate Director, Regulatory Advertising Promotion, Pain

Manager

• Evaluate future projects and initiatives for scoping, feasibility, and manage delivery of vetted and approved projects
• Guide discussions with stakeholders to gather and document business needs requirements
• Analyze, research, and recommend solutions to business problems in or pertaining to R&D Quality
• Analyze data and processes, including process mapping to identify areas for improvement
• Serve as the key conduit around communications within project teams to foster transparency and understanding between groups
• Communicate with wide range of stakeholders in Quality and other Business areas to ensure alignment and understanding
• Provide strategic input, technical and project management oversight to various functions across RDQA using project management standards (PMBOK, Lean Six Sigma)
• Work with cross functional departments and colleagues to ensure consistency, adherence, communication, training and appropriate application of project and change management tools and best practices
• Manage small, medium, and large-scale projects or process improvement initiatives, including enhancement and complex change management activities focused around operational excellence and organizational maturity
• Identify appropriate cross-functional project representatives and timing for engagement
• Conduct extensive research and investigations around proposed changes to understand root causes and identify gaps in process, outliers, anomalies, trends and patterns

Senior Manager, R&D Quality Project Lead

• Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence.
• Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality.
• Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, and risk identification.
• Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs.
• Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDAs.
• Provide input in the development of audit scope and focus for vendor audits.
• Contribute to proactive inspection readiness activities by conducting quality assessments of GLP studies on-site or remotely.
• Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities.
• Participate in creating and presenting content for annual GLP refresher training.
• Perform other duties as assigned.

Quality Manager / Sr. Manager, Good Laboratory Practices

• Provide biomarker quality leadership and oversight across GxP-related research, development, clinical trials, and potential commercialization into IVDs
• Collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence
• Support operational management oversight, audit strategy, regulatory document reviews (BBs, INDs, IDEs, TMFs)
• Develop scope for GCLP and GCP biomarker vendor audits and participate in vendor quality engagement
• Contribute to inspection readiness, design of quality metrics, governance meetings, and due diligence/integration activities

Associate Director, Regulatory Advertising Promotion, Pain

Senior Manager, R&D Quality Project Lead

Quality Manager / Sr. Manager, Good Laboratory Practices

Senior Manager, Biomarker Operational Quality